Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021346
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERDAL CONSTA RISPERIDONE 25MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription None Yes Yes
RISPERDAL CONSTA RISPERIDONE 37.5MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription None Yes No
RISPERDAL CONSTA RISPERIDONE 50MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription None Yes No
RISPERDAL CONSTA RISPERIDONE 12.5MG/VIAL INJECTABLE;INTRAMUSCULAR Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/29/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21346ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21346_RisperdalTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2019 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021346s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020272Orig1s082,020588Orig1s070,021444Orig1s056,021346Orig1s060Ltr.pdf
07/27/2018 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021346s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf
02/23/2017 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf
03/01/2016 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf
06/05/2014 SUPPL-52 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s052lbl.pdf
04/28/2014 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf
10/22/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/26/2013 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

10/10/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/12/2012 SUPPL-44 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf
09/24/2011 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf
06/15/2011 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf
12/07/2011 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf
12/01/2010 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf
08/30/2010 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf
08/30/2010 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf
09/24/2011 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf
08/24/2011 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf
08/30/2010 SUPPL-35 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf
07/19/2009 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf
12/07/2011 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf
08/30/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf
05/15/2009 SUPPL-28 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf
08/14/2008 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf
10/08/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf
05/15/2009 SUPPL-25 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf
10/08/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf
10/08/2008 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf
10/08/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf
03/09/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s020ltr.pdf
04/12/2007 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s015ltr.pdf
09/20/2006 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s013ltr.pdf
07/31/2006 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s011LTR.pdf
08/17/2005 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf
10/20/2006 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s009ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/25/2019 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021346s060lbl.pdf
07/27/2018 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021346s058lbl.pdf
02/23/2017 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf
03/01/2016 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf
06/05/2014 SUPPL-52 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s052lbl.pdf
04/28/2014 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf
12/07/2011 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf
12/07/2011 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf
09/24/2011 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf
09/24/2011 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf
08/24/2011 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf
06/15/2011 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf
12/01/2010 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf
08/30/2010 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
08/30/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
08/30/2010 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
08/30/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf
07/19/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
05/15/2009 SUPPL-28 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf
05/15/2009 SUPPL-25 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf
10/08/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf
10/08/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf
10/08/2008 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf
10/08/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf
04/12/2007 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf
03/09/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf
09/20/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf
08/17/2005 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf

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